The following data is part of a premarket notification filed by Curasan Ag with the FDA for Boneoptimizer.
| Device ID | K100841 |
| 510k Number | K100841 |
| Device Name: | BONEOPTIMIZER |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | CURASAN AG 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte, Ph.d. |
| Correspondent | Cynthia J.m. Nolte, Ph.d. CURASAN AG 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-25 |
| Decision Date | 2010-08-19 |
| Summary: | summary |